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Daratumumab earned approval for monotherapy due to its efficacy, safety profile and durable responses demonstrated in the phase 1/2 GEN501 and the phase 2 SIRIUS clinical trials on heavily pretreated RRMM patients [71, 72]

Peptides that only reduce inflammation without triggering repair do not qualify

5.2 Need for Concomitant Glucocorticoids and Monitoring for Other Diseases in Patients with Endocrine Disorders Occasionally, chronic autoimmune thyroiditis, which can lead to myxedema coma, may occur in association with other autoimmune disorders such as adrenal insufficiency, pernicious anemia, and insulindependent diabetes mellitus

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